Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2

Not Applicable

Completed

• Conditions: Infant, Very Low Birth Weight; Calcium Deficiency; Vitamin D Deficiency
• Interventions: Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily

• Registration Number: NCT01363167
• Lead Sponsor: Medical University of South Carolina

Brief Summary

This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-05-31
• Study First Posted: 2011-06-01
• Study Start: 2011-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-21
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Any infant born at the Medical University of South Carolina <34 weeks gestation
• Less that 1500g at birth
• AGA
• Must be African American or Caucasian
• Each infant born of twin and triplet pregnancies will be eligible

Exclusion Criteria

• Infants with major congenital anomalies or with hemolytic disease requiring exchange transfusion
• Infants born small for-gestational-age (SGA) or large for-gestational-age (LGA)
• Maternal uncontrolled thyroid disease
• Maternal Parathyroid disease
• Infants of races other than African American or Caucasian

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	400 IU Cholecalciferol- Vitamin D Daily	Placebo contains Fractionated Coconut Oil
400 IU Cholecalciferol - Vitamin D	400 IU Cholecalciferol- Vitamin D Daily	-

Primary Outcome Measures

Name	Time	Method
Intestinal Calcium Absorption	When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth
Parathyroid hormone concentration	At term age (expected 2-4 months)
Serum 25 hydroxyvitamin D status	At term age (expected 2-4 months)
Bone Health	At term age (expected 2-4 months)	Bone ultrasound measurement, serum alkaline phosphatase, and bone-specific alkaline phosphatase at birth and monthly until term age. Bone mineralization by DEXA scan at hospital discharge and term age.
Serum inflammatory cytokine concentrations	At birth (day 1)

Secondary Outcome Measures

Name	Time	Method
Phosphorus Homeostasis	At term age (expected 2-4 months)	Measurement of serum and urine phosphorus concentrations
Growth parameters	At term age (expected 2-4 months)
Vitamin D Dose Safety as Measured by Urinary Calcium Excretion	At term age (expected 2-4 months)

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States